Abdominal Wall Balloon To Treat Obesity

ABSTRACT

Disclosed are methods and apparatus for implantation into the walls of an organ such as the stomach. Deformable or inflatable anchors with a connector between are used to pull the walls of the organ together, or to implant devices in the wall of the organ. Also disclosed are surgical instruments useful in practicing the disclosed methods.

RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 11/125,547 which is a continuation-in-part of InternationalPatent Application No. PCT/US05/09322, filed Mar. 19, 2005, designatingthe United States, entitled “DEVICE AND METHODS TO TREAT A PATIENT,”which is a continuation-in-part of U.S. Non-Provisional patentapplication Ser. No. 10/974,248 filed Oct. 27, 2004, entitled “DEVICESAND METHODS TO TREAT A PATIENT,” which claims priority to U.S.Provisional Patent Application Ser. No. 60/556,004 filed Mar. 23, 2004by Michael Gertner, M.D., entitled “BARIATRIC DEVICES AND IMPLANTATIONMETHODS,” to U.S. Provisional Patent Application Ser. No. 60/584,219filed Jul. 1, 2004 by Michael Gertner, M.D., entitled “DEVICES ANDMETHODS FOR PERCUTANEOUS GASTROPLASTY,” to U.S. Provisional PatentApplication Ser. No. 60/603,944 filed Aug. 23, 2004 by Michael Gertner,M.D., entitled “DEVICES AND METHODS TO TREAT MORBID OBESITY,” all ofwhich are herein incorporated by reference in their entirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to methods and apparatus for implantingdevices in the walls of organs or vessels, including devices to apposethe walls of the stomach and blood vessels.

2. Description of the Related Art

Obesity is a public health problem of extreme national and internationalimportance. There are an estimated 60 million obese adults and 2 millionobese adolescents in the United States as of 2004. By some estimates,there are 1 billion obese individuals worldwide. Indeed, recent reportsestimate that over there are over 60 million obese individuals in China,a 10-fold increase since 2000. Obesity affects the life quality andproductivity of those effected and leads to long-term health relatedcomplications such as diabetes and heart disease. Some researchersestimate that if the obesity epidemic is not brought under control, itcould quickly overwhelm societal resources.

To date, surgery is the only proven method for inducing substantialweight loss. The mechanism behind the success of surgery is, in manycases, not known because obesity is such a complex, multifactorialdisease. Some researchers propose that surgery does no more than providebiofeedback for appetite retraining. Other researchers maintain thatsurgery alters the physiology of the patient such that satiety isinduced earlier or fewer nutrients are absorbed. Nonetheless, allresearchers agree that long-term weight loss is only possible bysurgical means.

Over the past four decades, there have been numerous surgical proceduresand devices developed to those who suffer from morbid obesity. Ingeneral, there are two physiologic components of all past and currentprocedures: malabsorption and mechanical restriction/volume reduction.

Many of the procedures performed in the past have proven to beimpractical, dangerous, and/or detrimental to patient health and are nowof historical importance only. One example of a failed procedure is thejejuno-ileo bypass in which a malabsorptive state was created throughthe bypass of a large portion of the intestine through the creation of asurgical anastomosis between the jejunum and the ileum. While patientsinitially lost a great deal of weight, liver failure or liver damageoccurred in over one-third of the patients which necessitated reversalof the surgical procedure.

One of the first restrictive type surgical procedures was the so-called“stomach stapling” operation in which a row of horizontal staples wasplaced across the upper stomach and then several staples were removedfrom the staple line to create an opening, the “os” for a small amountof food, but not too much food. This procedure was mostly restrictive,leading to an early feeling of satiety. This surgery was abandonedbecause 70%-80% of patients had inadequate weight loss due to stapleline dehiscence (i.e. the staples pulled through the stomach wall). Aprocedure to stabilize the staple line was performed by Smith et. al.(Lindsay B. Smith; Modification of the Gastric Partitioning OperationFor Morbid Obesity. Am. J. Surgery 142, December 1981) in which thestaple line was buttressed in the region where the staples were removedusing teflon pledgets with sutures passing through the middle of thepledgets. The purpose of the pledgets was to buttress the suture anddistribute the load across the suture to the pledget, thereby preventingthe suture from pulling through the stomach and therefore stabilizingthe os. The outcomes showed that the suture buttress was able to preventthe suture from tearing through the stomach wall.

The Roux-en-Y (The Roux) bypass operation has become the most commonlyperformed surgical procedure to treat the morbidly obese in the UnitedStates. It combines a small degree of malabsorption with a 90% reductionin the volume of the stomach. In the United States, 150,000 Rouxprocedures were performed in the year 2004. This number is expected torise to 500,000 procedures by 2007. The procedure actually has beenperformed since the late 1970's but has evolved substantially over thepast three decades into a relatively safe and effective procedure;indeed, the long-term data is very good. The advent of laparoscopicsurgery and hence the laparoscopic Roux-en-Y bypass in combination withexcellent follow-up results from the open procedure are reasons for theproliferation of the Roux procedure.

Despite the efficacy of the Roux procedure and the recent laparoscopicimprovements, it remains a highly invasive procedure with substantialmorbidity, including a 1-2% surgical mortality, a 20-30% incidence ofpulmonary morbidity such as pneumonia, pulmonary embolism, etc., and a1-4% chance of leak at the anastomotic site which can result in aspectrum of consequences ranging from an extended hospital stay todeath. Furthermore, it is not a good option for adolescents in whom thelong-term consequences of malabsorption are not known. In addition, manypatients resist such an irreversible, life altering procedure.

The Roux procedure requires general anesthesia and muscle paralysiswhich, in the morbidly obese population, is not of small consequence.There is also a substantial rate of anastomotic stricture which resultsin severe lifestyle changes for patients. As an example, many patientsare forced to vomit after meals. Furthermore, although minor whencompared to previous malabsorptive (e.g. jejuno-ileal bypass)procedures, the malabsorption created by the Roux-en-Y can dramaticallyaffect the quality of life of patients who undergo the procedure.

Recently, minimally invasive procedures and devices which create afeeling of early satiety have been introduced into the marketplace in anattempt to address some of the issues above. The LAP-BAND™ is a bandwhich encircles the stomach at the region of the fundus-cardia junction;it is a restrictive procedure similar to stomach stapling. It requiresgeneral anesthesia, a pneumoperitoneum, muscle paralysis, and extensivedissection of the stomach at the level the gastroesophageal junction.Although less invasive than the Roux procedure and potentiallyreversible, the LAP-BAND™ is nonetheless quite invasive. It also doesnot reduce the volume of the stomach and some patients report a feelingof hunger much of the time. In addition, long-term follow-up revealsthat the banding procedure results in many complications. In a recentlypublished article (Camerini et. al. Thirteen Years of Follow-up inPatients with Adjustable Silicone Gastric Banding for Obesity: WeightLoss and Constant Rate of Late Specific Complications. Obesity Surgery,14, 1343-1348), the authors reported a 60% prevalence of late bandremoval secondary to complications such as erosion, slippage of theband, infection, or lack of effectiveness. Nonetheless, the LAP-BAND™ asa procedure is becoming very popular across the world as it is perceivedto be a less invasive and reversible procedure. The weight loss inlong-term trials is considered adequate by some and inadequate by many;across the various studies, the average weight loss is approximately 40%of excess body weight (see below).

Other procedures which have been tried in the past and which offervarying degrees of weight loss include several variations of theoriginal “gastroplasty” procedures. These procedures represent anevolution of the so-called “stomach stapling” procedure discussed above.These procedures were attempted prior to and concomitant with theevolution of the Roux-en-Y. They became popular (despite potentiallyoffering less weight loss than the Roux) because of their substantiallyless invasive nature and possible reversibility.

One such example is called the vertical banded gastroplasty, or VBG,which again, created a restricting “os” for food. In the VBG, the borderof the “os” is the lesser curvature of the stomach which is less apt todilate than the fundus region of the stomach. Furthermore, the procedurecompletely excludes the fundus which is thought to easily dilate and infact, is physiologically “programmed” to dilate during meals . . .so-called “receptive relaxation.” One issue with the VBG is that, aspracticed today, it is not reversible, nor is it adjustable, and it isdifficult to perform laparoscopically. As in the horizontalgastroplasty, the VBG utilizes standard staplers which, as in thehorizontal gastroplasty, are unreliable when applied to the stomach. Inthe case of the VBG, the row of staples runs parallel to the lessercurvature of the stomach.

A recent, prospective, randomized trial, compared the VBG to theadjustable banding procedure and found that the VBG was overwhelminglysuperior to the banding procedure (Morino et. al. LaparoscopicAdjustable Silicone Gastric Banding Versus Vertical Banded Gastroplastyin Morbidly Obese Patients. Annals of Surgery. Vol. 238 (6) pps.835-842). Twenty five percent of the patients in the banding groupreturned to the operating room whereas there were no returns to theoperating room in the gastroplasty group. The degree of weight loss wasclose to 60% of excess body weight after three years in the gastroplastygroup and closer to 40% of excess body weight in the banding group.Although in this study, the VBG was successfully performedlaparoscopically, the laparoscopic VBG procedure is in fact, difficultto perform, because the procedure is not standardized and a “tool box”does not exist for the surgeon to carry out the procedure; furthermore,the procedure is not a reversible one and relies on the inherentlyunreliable stapler systems. A recent meta-analysis and systematic review(Buchwald et. al. Bariatric Surgery: A Systematic Review andMeta-analysis; JAMA vol. 292, no 14. pps 1724-1737) indicated thatvertical gastroplasty (avg. excess weight loss of 68.2%) is superior toadjustable banding (avg excess weight loss of 47.5%) and gastric bypass(avg excess weight loss of 61.6%).

The Magenstrasse and Mill (M&M) procedure is an evolving gastroplastytechnique wherein the greater curvature of the stomach is separated(stapled and cut) from the path of food, leaving a tube of stomach, theMagenstrasse, or “street of the stomach,” which is comprised of thelesser curvature. This procedure is similar to the VBG except that thelongitudinal staple line of the stomach extends further along the lessercurvature and into the antrum. The theory behind leaving the antral“mill” is that it will continue to serve its normal function of mixing,grinding, retropulsion, and well-orchestrated expulsion of chyme intothe duodenum. An authoritative study on the operation is incorporatedherein by reference (Johnston et. al. The Magenstrasse and MillOperation for Morbid Obesity; Obesity Surgery 13, 10-16).

In summary, the vertical gastroplasty procedure appears to be superiorto the banding procedure. However, the vertical gastroplasty procedureis not easily performed laparoscopically and furthermore, it is notreversible. Therefore, a need exists to standardize the vertical bandedgastroplasty and create a safer procedure which is also easy to perform,is durable and is reversible.

The intragastric balloon is not a new concept. The intragastric balloonis meant to displace volume within the stomach such that a smallervolume of food leads to an earlier feeling of satiety. Currently,intragastric balloons on the market are not fixed to the stomach. As aconsequence, the intragastric balloons lead to complications such asobstruction and mucosal erosion. As a consequence, the balloons areremoved after a maximum of six months. In a prospective, non-randomized,unblinded study (Sallet et. al. Brazilian Multicenter Study of theIntragastric Balloon; Obesity Surgery, 14, 991-998), the average excessweight loss was 48.3% after 1 year. However, the incidence of nausea andvomiting was 40% and epigastric pain was 20%; balloon impaction occurredin 0.6% of patients. A balloon which is fixed to the wall of the stomachcould potentially improve the intragastric balloon device and allowlonger-term implantation.

More recently, there has been an effort to develop even less invasivedevices and procedures which do not involve incisions at all. For themost part, these procedures are performed from within the stomach withan endoscope and by a phyisician with a high degree of endoscopic skill.For example, U.S. Pat. No. 6,558,400 describes methods and devices tocreate partitions in the stomach. Anchors or staplers applied through anendoscope from within the stomach are used to accomplish the partitions.Similarly, U.S. Patent Application Publication No. 2004/0122456describes another set of methods and devices to reduce the volume of thestomach. Expandable anchors are deployed both on the anterior andposterior wall of the stomach using an endoscope. Flexible sutures arebrought out of the patient's mouth and the sutures are crimped togetherwithin the stomach in order to bring the walls of the stomach closertogether. Patent application WO2004/004542 describes a device which isadvanced through an endoscope and grasps or applies suction to a fold ofmucosa to apply anchors through the mucosal and serosal layers of thestomach.

Endoscopic procedures to manipulate the stomach are time consumingbecause of the technical difficulty of the endoscopy; they also requirea large endoscope through which many instruments need to be placed forthese complex procedures. Due to the large size of the endoscope,patients typically will require general anesthesia, which limits the“non-invasive” aspects of the procedure. Furthermore, the proceduresrequire advanced endoscopic skill which would need to be acquired bymost endoscopic practitioners. Such skill adaptation can take asignificant amount of time, which will limit adoption of the procedureby the physician community. A further issue is that there is alimitation on the size of the anchors and devices which can be placedbecause the endoscope has a maximum size.

Percutaneous Endoscopic Gastrostomy (PEG) refers to a procedure in whicha gastrocutaneous tract is created using a percutaneous procedure (seebelow for definition). A recent update of the procedure can be found onthe Society of American Gastrointestinal Endoscopic Surgeons (SAGES)website, and is incorporated herein by reference. Briefly, the procedureinvolves insufflation of the stomach with and under visualization withan endoscope. A small incision is made in the skin and a needle isadvanced into the stomach (the stomach sits just under the abdominalwall when insufflated) under endoscopic visualization. A feeding tube isthen placed over the needle to create a gastrocutaneous tract with thefeeding tube inside the tract. The feeding tube is secured with anexternal bolster to creates a tubular tract from outside the patientthrough the skin of the abdominal wall and residing inside the stomach.Over the ensuing weeks, a permanent tract evolves between the stomachmucosa and epithelium of the skin, after which, the bolster can beremoved without consequence. When the feeding tube is to be removed, thegastrocutaneous tract will close on its own as food will preferentiallybe delivered antegrade (the path of least resistance) to the duodenum,thereby allowing the tract to heal.

SUMMARY OF THE INVENTION

In one embodiment, the current invention expands the scope ofpercutaneous gastrostomy in order to reduce the volume of the stomach,implant devices, and otherwise manipulate the stomach. Such procedurescan be easily adopted by the surgical community.

In one embodiment, a method for implanting an organ traversing device ina patient is disclosed. A first surgical instrument is placed adjacentto a second exterior surface of an organ. A first end of a secondsurgical instrument is passed through a patient's skin, through a firstexterior surface of the organ, through the interior of the organ, andthence through a second exterior surface of the organ, so that thesurgical instrument traverses the organ. The first surgical instrumentthen contacts the second surgical instrument and a first anchor isdeployed from the first surgical instrument wherein the first anchor islocated adjacent to the second exterior surface of the organ.Subsequently, a second anchor is deployed within the patient. At leastone connector is provided wherein the at least one connector contactsthe first anchor. The first and second anchors are stabilized byengaging the at least one connector with the first and second anchors.The anterior and posterior anchors can further be urged toward eachother such that a tensile stress then exists in the at least oneconnector. The second anchor can contact the second exterior surface ofan organ of a patient or it can contact one of the abdominal walllayers. The organ can be the stomach of a patient and the skin canoverlie the patient's stomach. The first exterior surface can be theanterior wall of the stomach and the second exterior surface of theorgan can be the posterior wall of the stomach.

The anterior and posterior walls of the stomach can be urged closertogether by shortening the length of the at least one connector. Thefirst or second surgical instrument can be inserted into the patient'sabdomen by directly penetrating the patient's skin and abdominal wall orby passing the surgical instrument through a laparoscopic port or bypassing the surgical instrument through an incision in the patient'sskin and abdominal wall.

In another embodiment, a method for treating a patient involves passinga first anchor through the skin of a patient and positioning the firstanchor adjacent to the posterior wall of the stomach and then passing atleast one connector through the patient's skin and thence through thepatient's anterior and posterior stomach walls to contact the firstanchor and the at least one connector, then passing a second anchorthrough the skin of a patient's abdominal wall. The first and secondanchors are linked by means of the at least one connector. The first andsecond anchors are urged toward each other and fixed to the connectoreither reversibly or irreversibly, thereby fixing the anterior andposterior walls of the stomach in the urged position with said first andsecond anchors.

In another embodiment, the second anchor is deployed within theperitoneal cavity and in yet another embodiment, the second anchor isdeployed between the abdominal skin and the outermost peritoneum of theabdominal cavity. In one embodiment, the first anchor passes through thepatient's abdominal skin while the first anchor is in a reduced profileconfiguration; subsequently the first anchor is expanded to reside in adeployed configuration.

The reduced profile configuration of the first anchor in someembodiments is substantially folded, and/or compressed, and/oruninflated, and said deployed configuration is substantially unfoldedand/or uncompressed and/or inflated.

The reduced profile configuration of the second anchor in someembodiments is substantially folded, and/or compressed, and/oruninflated, and said deployed configuration is substantially unfoldedand/or uncompressed and/or inflated.

In some embodiments, the anchor implantation method is repeated foradditional anchors. In some embodiments, the mucosa of said anterior andposterior walls of the stomach do not contact one another (or when theydo contact one another, food can continue to pass through even though ata slower rate) when said first and said second anchors are fixed intheir urged positions. In other embodiments, the mucosa of said anteriorand posterior walls contact one another tightly (prevent food frompassing) when said first anchor and said second anchor are fixed intheir urged positions. In some embodiments, an electrical signal isdelivered to the anterior stomach wall through the second anchor. Insome embodiments, an electrical signal is delivered to the posteriorstomach wall through a first anchor. In some or all embodiments, anendoscope is not used to grasp the stomach.

In another embodiment, a method for fastening or otherwise applying orimplanting a therapeutic device to a wall of a gastrointestinal organ isdescribed. The therapy device is passed through a patient's abdominalskin and into or close to the serosa of a gastrointestinal organ. Insome embodiments, the therapy device is in an undeployed configurationand is subsequently deployed in the serosa or muscular layers of thegastrointestinal organ. In some embodiments, a connector is alsoprovided for attachment to the therapy device. In some embodiments, ananchor is further placed through the abdominal skin of a patient whilethe anchor is in an undeployed configuration. The anchor is subsequentlydeployed in the serosal or muscular layers of the organ or in theabdominal wall; in this embodiment, pneumoperitoneum is not necessarynor is penetration of the mucosal layer of the organ. In someembodiments, the anchor is connected to the therapy device by means ofthe connector. The method of this embodiment can also be applied tonon-permanent (non-implantable) devices; for example, a temporary orpermanent therapeutic energy source can also be applied to thegastrointestinal organ without a generalized pneumoperitoneum. Examplesof temporary energy sources in this embodiment include but are notlimited to radiofrequency generators, microwave generators, lasergenerators, or ultrasound generators.

In one embodiment, a method of treating a patient is described in whicha surgical device having a reversibly engaged first anchor is positionednear an organ or organ-organ connection or anastomosis of a patient. Anelongate member, which has a proximal end, a distal end, and acircumferential wall sized to receive at least one connector, ispositioned or formed in a patient. The distal end of the connector isthen engaged by the first anchor after the distal end of the connectoris advanced through the lumen of the elongate member, through a firstportion of the organ and thence through a second portion of the organ.The first anchor is then released from the surgical device such that thefirst anchor remains engaged with the connector. Subsequently, a secondanchor is advanced over the connector while tracking along theconnector. The first and second anchors are then urged together, thesecond anchor is released such that it engages the connector. Theconnector is then cut such that its length defines the distance betweenthe first and second anchors.

The organ, or organ-organ anastomosis of treatment can be one of: thestomach, lung, colon, intestine, liver, spleen, a vein, an artery, thesmall intestine, a gastroenterostomy, a gastrojejunostomy, acolo-colostomy, or a colo-enterostomy.

In another embodiment, a method for creating a feeling of fullness in apatient involves passing a volume displacing device through the skin ofa patient and into the space between the abdominal musculature and theanterior wall of the stomach. The volume displacing device has anexpandable portion and a connector portion. The expandable portion isthen expanded. The volume displacing device is then secured to theabdominal wall by tracking a anchor over the connector portion of thevolume displacing device and deploying the anchor. When the anchor isdeployed on the connector, the anchor is prevented from moving furtheralong the connector. In some embodiments, the volume expandable portionof the volume displacing device is fixed to the serosa of the stomachand does not penetrate the mucosal layer. In some embodiments, theconnector is cut at the level of the anchor.

In some embodiments, the anchor connector system or systems in any ofthe embodiments of the invention is adjusted from within the stomachafter the fastening system is placed and after the connector is cut.Adjustability of the transgastric fastening system is advantageous overthe prior art.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1E are perspective views of embodiments of the posterior anchorand connector.

FIGS. 1F and 1G are side views of an inflatable embodiment of posterioranchor and connector.

FIGS. 1H, 1I, and 1J are views of suture-connector—posterior anchorcombinations in which the connector is separable from the posterioranchor.

FIG. 1K is a view of a connector-anchor combination in which the lengthbetween two anchors is adjustable.

FIGS. 2A and 2B are a perspective view and top view of one embodiment ofan anterior anchor, respectively.

FIGS. 2C and 2D are side sectional views of the embodiment of theanterior anchor of FIGS. 2A and 2B, taken along the line B-B in FIG. 2B,in its deployed and reduced profile configuration, respectively.

FIGS. 2E and 2F are side sectional views of another embodiment of ananterior anchor, taken along the same line as FIGS. 2C and 2D, in itsdeployed and reduced profile configuration, respectively.

FIGS. 2G is a perspective view of an inflatable embodiment of ananterior anchor.

FIGS. 2H and 2I are side sectional views of the embodiment of theanterior anchor of FIG. 2G, taken along the line D-D in FIG. 2G, in itsdeployed and reduced profile configuration, respectively.

FIG. 3A is a perspective view of another embodiment of an anterioranchor.

FIGS. 3B and 3C are perspective views of the embodiment of the anterioranchor shown in FIG. 3A in its reduced profile and deployedconfiguration, respectively.

FIG. 3D is a perspective view of another embodiment of an anterioranchor.

FIGS. 4A and 4A′ are a side and blow-up view, respectively, of oneembodiment of a tissue grasping instrument with the distal end in itsopen configuration.

FIGS. 4B and 4B′ are a perspective and blow-up view, respectively, ofthe tissue grasping instrument of FIG. 4A with the distal end in itsclosed configuration.

FIGS. 4C and 4C′ are a perspective and blow-up view, respectively, ofanother embodiment of the tissue grasping instrument with the distal endin its closed configuration.

FIG. 5A is a side view of one embodiment of an anchor implantationinstrument.

FIG. 5B is a perspective view of the distal end of the anchorimplantation instrument of FIG. 5A and an anterior anchor and connector.

FIG. 5C is a side sectional view of the distal end of the anchorimplantation instrument of FIGS. 5A and 5B, taken along line C-C in FIG.5B, with the anterior anchor in its reduced profile configuration.

FIG. 6A illustrates the first step in one embodiment of a method ofreducing the volume of the stomach. Shown is a side sectional view of apatient's abdomen with the instrument of FIG. 4 inserted into thepatient's abdomen through a laparoscopic port.

FIG. 6B illustrates the next step in one embodiment of a method ofreducing the volume of the stomach. Shown is a side sectional view of apatient's abdomen with the instrument of FIG. 4 grasping the posteriorwall of the stomach and a needle being inserted into the potential spaceof the lesser peritoneal sac.

FIG. 6C illustrates the next step in one embodiment of a method ofreducing the volume of the stomach. Shown is a side sectional view of apatient's abdomen with the instrument of FIG. 4 grasping the posteriorwall of the stomach and a posterior anchor and connector deployed in theexpanded potential space of the lesser peritoneal sac.

FIG. 6D illustrates the next step in one embodiment of a method ofreducing the volume of the stomach. Shown is a side sectional view of apatient's abdomen with a posterior anchor and connector deployed in theexpanded potential space of the lesser peritoneal sac, with theconnector passing out of the patient's abdomen through a laparoscopicport.

FIG. 6E illustrates an alternative step and device to place theposterior anchor in which the posterior anchor is brought behind thestomach before the connector is attached.

FIG. 7A illustrates the next step in one embodiment of a method ofreducing the volume of the stomach. Shown is a side sectional view of apatient's abdomen with the instrument of FIG. 5C placing an anterioranchor in the patient's abdomen adjacent to the anterior wall of thestomach.

FIG. 7B illustrates the next step in one embodiment of a method ofreducing the volume of the stomach. Shown is a side sectional view of apatient's abdomen with an anterior anchor in its deployed configurationon the connector, with the anterior and posterior walls of the stomachurged together.

FIG. 7C illustrates the next step in one embodiment of a method ofreducing the volume of the stomach. Shown is a side sectional view of apatient's abdomen after the connector has been cut flush with theanterior anchor.

FIG. 8A illustrates an embodiment of a method of reducing the volume ofthe stomach. Shown is a side sectional view of a patient's abdomen aftertwo posterior anchors and connectors have been deployed adjacent to theposterior wall of the stomach, with the connectors passing out of thepatient's abdomen through laparoscopic ports.

FIG. 8B shows the connectors of FIG. 8A with clamps placed on theconnectors outside the patient's body to temporarily hold the connectorsin a test position.

FIG. 9 is a perspective view showing three transgastric fasteningassemblies deployed longitudinally in a patient's stomach.

FIG. 10A illustrates one embodiment of a method for deploying a volumedisplacing device in the stomach. Shown is a side sectional view of apatient's abdomen after an uninflated balloon anchor has been insertedinside the patient's stomach with a connector passing out of thestomach, through the anterior stomach wall, and through a laparoscopicport.

FIG. 10B illustrates one embodiment of a method for deploying a volumedisplacing device in the stomach. Shown is a side sectional view of apatient's abdomen with the balloon anchor in its deployed position, heldin place by an anterior anchor and connector.

FIG. 11A illustrates a volume displacing device which resides outsidethe stomach and is shown in an undeployed state.

FIG. 11B illustrates a volume displacing device which resides outsidethat stomach and is shown in a deployed state and attached to theabdominal wall and with an anterior anchor and connector.

FIG. 11C illustrates a volume displacing device which resides outsidethe stomach and is fixed to the anterior wall of the stomach and to theabdominal wall with an anterior anchor and connector.

FIG. 12 illustrates another step in the laparoscopic method of placing adevice in the stomach.

FIG. 13 illustrates another step in the laparoscopic procedure in whichthe anterior anchor is urged toward the posterior anchor over aconnector.

FIG. 14 a illustrates another step in the laparoscopic procedure inwhich the anterior and posterior walls of the stomach are urgedtogether.

FIG. 15 a illustrates the initial retrogastric step in the laparoscopicprocedure.

FIG. 15 b depicts a horizontal row of transgastric anchors andconnectors after placement in the stomach.

FIG. 16 depicts anchors of the present invention being used to secure anendoscopically placed gastric implant.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Anatomy of the Stomach

The region behind the stomach is referred to as the lesser peritonealsac. It is a potential space between the retroperitoneum and theposterior wall of the stomach. To the left of the midline, the posteriorwall of the stomach is generally free from the peritoneal surface of theretroperitoneum. To the right of the midline, the posterior wall of thestomach is more adherent to the retroperitoneum although the adherenceis generally loose and the adhesions can be broken up rather easily withgentle dissection.

The stomach is comprised of several layers. The inner layer is themucosa. The next layer is the submucosa followed by the outer muscularlayers. Surrounding the muscular layers is the serosal layer. This layeris important with regard to implants and healing because it is theadhesive layer of the stomach; that is, it is the layer which, whenbreached, heals with scar tissue formation. Implants adhering to thislayer are less likely to migrate into the stomach. Reference to “stomachwall” or “wall of the stomach” as used herein include the entirethickness of the stomach, including the mucosa, submucosa, muscularlayers, and serosa. The “anterior wall of the stomach” is the portion ofthe stomach closest to the muscular abdominal wall and the “posteriorwall of the stomach” is the part of the stomach closest to theretroperitoneum.

“Transgastric fastening assembly” or “fastening system” refers to apermanent or semi-permanent implant and comprises at least one posterioranchor, at least one anterior anchor, and a connector to couple theposterior and anterior anchors. The “connector” can refer to any meansof connection including but not limited to a material connection, anelectromagnetic connection, or a chemical connection. As used herein, a“connector” is a coupler or linker used to materially connect theanterior and posterior anchors. As used herein, the “posterior anchor”is the anchor in a preferred embodiment which is adjacent to theposterior wall of the stomach when deployed. The “anterior anchor” isthe anchor in a preferred embodiment which is approximated to theanterior wall of the stomach when deployed.

As used herein and when referring to portions of a surgical instrument,“proximal” refers to the end of the instrument which is closest to thesurgeon when the instrument is used for its intended purpose, and“distal” refers to the end of the instrument which is closest to thepatient when the instrument is used for its intended purpose. When usedto refer to the gastrointestinal tract, “proximal” is toward the mouthand “distal” is toward the anus.

“Laparoscopic procedure” broadly refers to procedures which requirepneumoperitoneum and general anesthesia. “Percutaneous procedure”broadly refers to surgeries which do not require general anesthesia orpneumoperitoneum. These broad terms are mutually exclusive for thepurposes of the ensuing invention because the respective proceduresrequire different levels of patient preparation and peri-operativetreatments. In some descriptions, the terminology “percutaneous means”is used which generically refers to placing a surgical instrumentthrough the skin of a patient and using the surgical instrument toaccomplish a surgical task; in this more generic case, “percutaneousmeans” can be used with or without laparoscopy. Similarly, “laparoscopicmeans” generically refers to procedures performed under the guidance ofan internal camera; in this more generic sense, laparoscopy can be usedwith or without percutaneous methodology though in most casespercutaneous methodology is preferred.

Structures

Transgastric Fastening Assembly

Referring to FIGS. 1A and 1B, one embodiment of the posterior anchor 14and connector 12 are shown in a deployed configuration (FIG. 1A), andreduced profile configuration (FIG. 1B). The connector 12 is preferablymade of a flexible, biocompatible polymer, but it can be made fromvarious kinds of suitable biocompatible materials known to those ofskill in the art including metals, such as titanium and platinum, metalalloys, such as stainless steel, nickel-titanium, and cobalt-chromium,man-made polymers, such as polyurethane, silicone elastomers,polyglycolic acid, polylactic acid, poly (ε-caprolactone),polyvinylidene fluoride (PVDF), PTFE, FEP, polypropylene, or naturalfibers such as silk; bioartificial materials include allogenic andxenogenic collagen based products. These materials can be used singly orin combination. For example, one portion of the connector may bebioabsorbable and another portion of the connector may be permanent. Theconnector 12 can vary in thickness, shape, and rigidity. For example, inthe embodiment shown in FIG. 1A, the connector 12 is substantiallyrod-shaped, with a circular cross-section, and is flexible. Those ofskill in the art will recognize that the cross-section of the connectorcan be any of a number of shapes, such as square, hexagonal, oval, etc.In other embodiments, the connector 12 is thin and flexible, such as asurgical suture, and in still others it is rigid. The connector can havea thickness ranging from 100 microns (e.g. suture) to severalmillimeters depending on the application. Although a single connector isdepicted as being attached to the posterior anchor, those skilled in theart will recognize that more than one, or several connectors can beconnected to the anchor at different points on the anchor or as acombination attached to one point on the anchor (e.g. a bundle).

In a preferred embodiment, the posterior anchor 14 is made from abiocompatible, radio-opaque or magneto-opaque semi-rigid polymer; it canalso be made from various kinds of suitable materials known to those ofskill in the art including metals, metal alloys, plastics, naturalmaterials or combinations thereof as discussed above in relation to theconnector 12. In some embodiments, the anchor is made from a conductivematerial and in other embodiments, the anchor is made from a combinationof conducting, non-conducting, and/or semi-conducting materials. Theposterior anchor 14 can be solid, or alternatively, can be porous,mesh-like, lattice-like, or umbrella-like. In some embodiments, theanchor contains a potential space on the inside which can be expanded bya fluid (e.g. gas or liquid). In a preferred embodiment, the posterioranchor is porous or has a porous mesh attached to it to encouragefibrous ingrowth such that it becomes permanently attached to thestomach or intestinal wall. Coatings can be added to the anchor toencourage tissue ingrowth; of course, such coatings do not limit theability for the interior of the anchor to be a potential space forexpansion by a fluid. In other embodiments, the posterior anchor issolid and/or treated to discourage tissue ingrowth (e.g. with a siliconecoating). In other embodiments, the posterior anchor has a xenograft orallograft material attached to the anchor. In a preferred embodiment,the posterior anchor 14 is disc-shaped, but those of skill in the artwill recognize that other embodiments are possible, such as those shownin FIGS. 1C and 1D, or disclosed in U.S. Patent Application PublicationNo. 2004/0122456 which is herein incorporated by reference; noteparticularly the description of anchor structures. The posterior anchor,in other embodiments, can be rectangular or diamond shaped. Theposterior anchor can also be bioabsorbable in whole or in part in someembodiments. The largest dimension of the posterior anchor can rangefrom about 5 mm to about 10 cm depending on the application and themanner in which it is implanted (see below). In the case where theposterior anchor is a disc shape, the diameter is considered the largestdimension.

In the embodiment shown in FIGS. 1A and 1B, the connector 12 is fastenedto the posterior anchor 14 at an attachment point 16 which is preferablya permanent, e.g. welded or molded, connection. Such a weld orconnection can comprise, for example, a thermoformed polymer, a metallicweld, or a molded or other integral structure. In a preferredembodiment, a biocompatible thermoformed polymer is used because of itsflexibility and ability to yield to the continuous motion of thestomach. More preferably, the connector and posterior anchor areproduced as a single, continuous structure (e.g. through an injectionmolding process).

Other suitable means of fastening the connector to the posterior anchorare also contemplated and do not necessarily result in a connector andposterior anchor becoming permanently attached. For example, in oneembodiment shown in FIG. 1C, one end of the connector is passed througha hole 20 near the center of the posterior anchor 22, and a stop 24,such as a knot or enlarged molded region, is formed on the end of theconnector to prevent its passage back through the hole in the posterioranchor. In this embodiment, the posterior anchor 22 can be free to movealong the length of the connector 26, but is prevented from beingremoved from one end of the connector by the stop 24.

In the embodiment shown in FIGS. 1A and 1B, the posterior anchor 14preferably has a deployed configuration (FIG. 1A), and reduced profileconfiguration (FIG. 1B). The posterior anchor 14 can be deformed to afolded configuration wherein its profile is reduced to facilitateinsertion of the anchor through the walls of the stomach or other tissueas described in more detail below. In one embodiment, the posterioranchor 14 is made of a semi-flexible material having shape memory, sothat once the anchor is deployed within the patient, it will return toits original shape shown in FIG. 1A, preventing it from being easilypulled back through the tissue. Preferably, the posterior anchor isinflatable in place of, or in addition to, having shape memory, whichallows for a much larger deployed profile relative to its undeployedprofile (see below). In some embodiments, the posterior anchor containsan intrinsic magnetic, ferromagnetic, or paramagnetic material.

FIGS. 1D and 1E show an alternative embodiment of the posterior anchor30 and connector 32 in a deployed configuration (FIG. 1D), and a reducedprofile configuration (FIG. 1E). In this embodiment, the posterioranchor 30 is elongated, having major and minor dimensions, andpreferably having a rod or bar shape. By aligning the connector 32substantially parallel to the posterior anchor 30, its profile isreduced to facilitate insertion of the anchor through the walls of thestomach or other tissue. When the anchor leaves its surrounding sheath(see below), tension on the connector 32 in the direction of the arrowin FIG. 1E will urge the posterior anchor 30 into a substantiallyperpendicular orientation relative to the connector 32, as shown in FIG.1D, preventing it from easily being pulled back through the tissue. Theconnection between the posterior anchor 30 and the connector 32 can behinged. Alternatively, the connector 32 can be made of a semi-rigidmaterial which is permanently connected or welded to the posterioranchor 30. If the connector is deformed to a bent position, shown inFIG. 1E, it will return to its original straight shape shown in FIG. 1Donce the anchor is deployed within the patient, preventing the posterioranchor from easily being pulled back through the tissue. This anchor 30can be inflatable as well, which allows for a much larger deployedprofile relative to its undeployed profile.

In a preferred embodiment, shown in FIGS. 1F and 1G, the posterioranchor is inflatable. The anchor has an inflatable disc-shaped body 34which is readily deformable when in its reduced profile (i.e.,uninflated) configuration as shown in FIG. 1F. In the preferredembodiment, the posterior anchor body 34 is disc-shaped, but those ofskill in the art will recognize that other embodiments are possible,such as those shown in FIGS. 1C and 1D, or in which the inflatableanchors are square shaped, rectangular, or amorphous, or have a shapedisclosed in U.S. Patent Application Publication No. 2004/0122456 whichis herein incorporated by reference; note particularly the descriptionof anchor structures. The body can be inflated with a substancedelivered through a hollow connector 35. When the interior space 36 ofthe anchor body is inflated, the anchor assumes its deployedconfiguration shown in FIG. 1G. Once the body is inflated, it can becomesubstantially less compliant yet remain soft and pliable.

The inflatable posterior anchor can have a valve 38 located between theanchor body 34 and the connector 35. Alternatively, the valve is locatedin the portion of the connector located outside the patient, the valve(e.g. stopcock type valve) being controlled by the operator until theanterior anchor is placed (see below). In this alternative embodiment,the filling substance is trapped in the posterior anchor after theanterior anchor is deployed and the connector is cut and sealed,preferably flush with the anterior anchor (see below). The fillingsubstance can be a gas, liquid, or material which changes phase withtime (i.e. it may harden, cure, polymerize, or become a gel with time).Preferably, the surface of the posterior anchor adjacent to theposterior wall of the stomach has a mesh fixed to it to encourage tissueingrowth. In some embodiments, part, or all of the anchor material iscomprised of a biodegradable material.

FIG. 1H depicts another embodiment of the current invention. Theposterior anchor 37 and the connector 39 are separable in thisembodiment. A second connector 33 is disposed within the first connector39. The second connector can be one or more sutures. This fasteningassembly would be used in a laparoscopic procedure where the connector39 would be placed through an organ before engaging the posterior anchor37. In some embodiments, the posterior anchor can be as large as thewidth of the organ (e.g. 8-10 cm in the case when the organ is thestomach). In some embodiments, the anchor 37 can be as small as 5 mm or1 cm. The anchor 37 can also be adapted to accommodate severalconnectors rather than one connector at a time. The first connector 39is adapted to engage the posterior anchor 37 after passing throughtissue (e.g. the stomach). In one embodiment, the first connector has aninner diameter with a second connector (e.g. a suture) traveling throughits lumen. After contact between the outer connector 39 and theposterior anchor 37, the outer connector 39 is removed, leaving theinner connector 33 (e.g. the suture) attached to the posterior anchor 37(FIG. 1J). The connection of the suture to the posterior anchor isaccomplished by any mechanical means well known to those skilled in theart.

FIG. 1K depicts another embodiment of the current invention in which theconnector 47 in this embodiment is configured so that its length isadjustable. In this embodiment, the connector is split (e.g. two suturesare used). The housing 45 is attached to one half of the connector 47and this half of the connector is attached to the posterior anchor 49.Within housing 45, the connector 47 can be shortened (and the tensionbetween thehh two anchors increased) by turning inner cylinder 48 whichchanges the distance (and the tension on the connector) between the twoanchors 49,51. Such adjustment can be done with an endoscope and can bedone after (days, months, years) implantation of the fastening systemwithin an organ such as the stomach.

Although FIGS. 1 a-k depict a single connector contacting the posterioranchor, those skilled in the art will recognize that more than oneconnector can be used to contact the posterior connector. The more thanone connector can be placed in any arrangement along the posterioranchor (e.g. in a row, in a pattern along the perimeter, or concentratedin the center). The more than one connector can be bundled and attachedin one place on a second anchor or in multiple point on a second anchor.

FIGS. 2A (perspective view) and 2B (plan view) show an embodiment of theanterior anchor 40. The anterior anchor has a disc-shaped body 42 with ahole or other passageway 44 substantially in the middle of the body.Although the hole is shown in the center of the anchor, those skilled inthe art will recognize that the hole can be placed anywhere along theface of the anterior anchor and/or more than one hole can be created inthe anchor. Two gripping elements 46 project into the center of the holeor other passageway. With respect to the gripping elements, there can beas few as one or more than two. The gripping elements can circumscribethe entire opening or they can be discrete components 46. The grippingelements can be macroscopic as shown in FIG. 2A or they can bemicroscopic like sandpaper (not shown). The gripping elements may haveteeth 50 angled toward the top surface of the anchor. Optionally, twohooks 52, or other graspable recesses, appendages, or structures, arelocated on the top surface of the anterior anchor. Hooks 52 allow forattachment of a surgical instrument during deployment of the anterioranchor in the patient as described below. Alternatively, there can benone, one, two or more than two graspable recesses, appendages, orstructures on the top surface of the anchor. In the preferredembodiment, the anterior anchor body 42 is disc-shaped, but those ofskill in the art will recognize that other embodiments are possible, asdisclosed in U.S. Patent Application Publication No. 2004/0122456 whichis herein incorporated by reference; note particularly the descriptionof anchor structures. The anterior anchor can also be wholly comprisedof or only partially comprised of one or more magnetic components.Alternatively, in other embodiments, the anterior anchor carries one ormore weights within it such that gravity causes the intestinal walls tocome together as a result of the weights within the anchors.

FIGS. 2C and 2D are cross sections of the anterior anchor of FIGS. 2Aand 2B, taken along the line B-B in FIG. 2B. FIG. 2C shows the anterioranchor in its deployed configuration with the connector 12 of FIG. 1Apassing through the hole or other passageway 44 in the body of theanchor. In the deployed configuration, the gripping elements 46 andteeth 50 engage the connector 12 with sufficient pressure to preventmovement of the anchor along the connector 12 in the direction of thearrow in FIG. 2C, which would increase the distance between the anterioranchor and posterior anchor (not shown). In the case where the connectoris a suture, the surface of the suture can be roughend to enablegripping by the anchor. In FIG. 2D, the anterior anchor 40 is in itsreduced profile configuration with the connector 12 of FIG. 1A passingthrough the hole or other passageway 44 in the body of the anchor.Preferably, the anterior anchor is made of a semi-rigid polymer whichallows the anchor to be deformed into a substantially foldedconfiguration illustrated in FIG. 2D. When in this configuration, thegripping elements 46 and teeth 50 do not significantly engage theconnector 12. This allows movement of the anterior anchor 40 along thelength of the connector 12 in the directions illustrated by the arrowsin FIG. 2D. Once the anterior anchor is in the desired position alongthe connector 12, the anterior anchor is permitted to return to theconfiguration shown in FIG. 2C, and the gripping elements 46 and teeth50 engage the connector 12, thus preventing movement between theconnector 12 and the anterior anchor 40.

In an alternative embodiment, it is contemplated that the connector 12can have notches 51, which interact with gripping elements 46 in aratchet-and-pawl mechanism similar to that used in cable ties, providinga one-way adjustability, in which the posterior and anterior anchors canbe moved toward each other, but not away from each other.

FIGS. 2E and 2F illustrate another embodiment of an anterior anchor 60which is similar to the one illustrated in FIGS. 2C and 2D. In FIG. 2E,the gripping elements 62 and teeth 64 are oriented so that the anterioranchor can be deformed such that the top surface of the anchor is foldedinward as illustrated in FIG. 2F. This is in contrast to the embodimentillustrated in FIG. 2D where the bottom surface of the anchor is foldedinward. The teeth 64 in FIG. 2E are angled toward the top surface of theanterior anchor and engage the connector 12 of FIG. 1A such that theyprevent movement of the anterior anchor along the connector 12 in thedirection of the arrow in FIG. 2E, which would increase the distancebetween the anterior anchor and posterior anchor (not shown).

FIG. 2G is a perspective view of a preferred embodiment where theanterior anchor is inflatable. The anterior anchor has a hollow,inflatable disc-shaped body 65 with a hole or other passageway 66substantially in the middle of the body. Two gripping elements 67project into the center of the hole or other passageway, although therecan be as few as one or more than two gripping elements. The grippingelements can have teeth 68 angled toward the top surface of the anchor.Alternatively, in a preferred embodiment, the gripping elements are inthe form of a rough surface rather than the protruding elements as shownin FIG. 2G. Such a surface, which may be a sandpaper-like surface,creates enough friction to prevent movement in either direction alongthe connector. Optionally, two hooks 69 are located on the top surfaceof the anterior anchor. Hooks 69 facilitate grasping by a surgicalinstrument during deployment of the anterior anchor in the patient asdescribed below. Alternatively, rather than hooks, there can be one ormore graspable protrusions on the body. In yet another embodiment, thereare no hooks or graspable protrusions, and the body of the anchor isgrasped directly to manipulate the anchor. In another embodiment,protrusions 69 are magnetic or otherwise sticky (e.g. Velcro) in natureto facilitate attachment to a surgical instrument.

An inflation tube 63 is used to inflate and deflate the anterior anchor.This inflation tube may or may not have a valve. In one preferredembodiment, the anterior anchor is filled with gas or fluid through theinflation tube and the fluid is held inside the anchor through anexternal (e.g. stopcock) valve controlled by the operator. When theinflation tube is cut at the end of the procedure, the inflation line iscrimped closed thereby locking the inflating substance inside theanchor. Alternatively, the shears used to cut the inflation line can bemetal and an electrocautery current can be applied through the shearsand to the inflation line to weld it closed.

FIGS. 2H and 2I are cross sections of the anterior anchor of FIG. 2G,taken along the line D-D in FIG. 2G. The disc-shaped body 65 is readilydeformable when in its reduced profile (i.e., uninflated) configurationas shown in FIG. 2I. The body can be inflated with a substance deliveredthrough the inflation tube 63. When anchor body is inflated, the anchorassumes its deployed (i.e. inflated) configuration as shown in FIG. 2Hwith the connector 12 of FIG. 1A passing through the hole 66 in the bodyof the anchor. In the deployed configuration, the gripping elements 67and teeth 68 engage the connector 12 with sufficient pressure to preventmovement of the anchor along the connector 12 in the direction of thearrow in FIG. 2H, which would increase the distance between the anterioranchor and posterior anchor (not shown). Alternatively, rather thandefined gripping elements and teeth, the surface of body which definesthe sides of the hole or other passageway 66 can be configured such thatwhen the anchor body is inflated, the sides of the hole or otherpassageway expand to substantially close off the hole or otherpassageway and limit movement of the anchor relative to the connectorthrough friction between the connector and the anchor.

In FIG. 2I, the anterior anchor 65 is in its reduced profile (i.e.uninflated) configuration with the connector 12 of FIG. 1A passingthrough the hole 66 in the body of the anchor. When in thisconfiguration, the anchor body is readily deformable and the grippingelements 67 and teeth 68 do not significantly engage the connector 12.This allows movement of the anterior anchor 65 along the length of theconnector 12 in the directions illustrated by the arrows in FIG. 2I.Once the anterior anchor is in the desired position along the connector12, the anterior anchor is inflated by a filling substance deliveredthrough the inflation tube 63, and the anchor assumes its deployed (i.e.inflated) configuration as shown in FIG. 2H; the gripping elements 67and teeth 68 engage the connector 12, thus restricting movement of theanterior anchor 65 in one or both directions along the length of theconnector 12. The filling substance can be a gas, liquid, or materialwhich changes phase with time (i.e. it may harden, cure, polymerize, orbecome a gel with time).

FIG. 3A illustrates another embodiment of an anterior anchor 70consisting of two parts, an anchor body 72 and a readily deformablecollar 74. The anchor body and collar have a central hole or otherpassageway (76 and 78 respectively) through which the connector canpass. Preferably, the anterior anchor body is made of a semi-rigidpolymer which can be deformed into a folded configuration with a reducedprofile as illustrated in FIG. 3B. Preferably, the readily deformablecollar 74 is permanently deformable; i.e., once deformed, it does notreturn to its original shape. As illustrated by the arrow in FIG. 3B,both the collar 74 and anchor body 72 can move along the connector 12 ofFIG. 1A. Once the anchor body 72 is in the desired position, the collar74 is crushed, such that the collar 74 engages the connector 12 and canno longer move along the length of the connector 12. This prevents theanchor body 72 from moving along the length of the connector 12 in thedirection of the arrow illustrated in FIG. 3C, which would increase thedistance between the anterior anchor and posterior anchor (not shown).FIG. 3D illustrates an alternative embodiment of the anterior anchor 80,where the anchor body 82 and deformable collar 84 are a single piece.

In a preferred embodiment, the anterior anchor is made from abiocompatible, radio-or magneto-opaque polymer, but it can also be madefrom various kinds of suitable materials known to those of skill in theart including metals, metal alloys, plastics, natural materials orcombinations thereof as disclosed above. The anterior anchor can besolid, or alternatively, can be porous, mesh-like, umbrella-like orlattice-like. In a preferred embodiment, the anterior anchor is porous,mesh-like, umbrella-like or lattice-like to encourage fibrous ingrowthsuch that it becomes permanently attached to the stomach wall. Coatingscan be added to the anchor, or a mesh material such as polypropylene canbe fixed to the anchor surface, such that it touches the anteriorstomach wall and encourages tissue ingrowth. In other embodiments, theanterior anchor is solid and treated to discourage tissue ingrowth withmaterials such as silicone, PTFE, or FEP which are generally hydrophobicand non-reactive. In other embodiments, the anterior anchor has axenograft or allograft material attached to the anchor which ensurestissue ingrowth. In a preferred embodiment, the anterior anchor isdisc-shaped and substantially flat, but those of skill in the art willrecognize that other embodiments are possible.

Surgical Instruments

FIG. 4A illustrates one embodiment of a tissue grasping instrument 200.The tissue grasper has a tubular outer sleeve 210 to which a portion ofa handle 212 is attached at the proximal end. As shown in more detail inthe blow-up, FIG. 4A′, disposed within the outer sleeve 210 is a tubularinner member 214 which has an outer diameter such that it can slidewithin the outer sleeve 210 in the longitudinal axis of the outer sleeve210 but cannot move substantially transverse to the longitudinal axis ofthe outer sleeve 210. At the proximal end of the inner member, a secondportion of a handle 216 is attached. At the distal end of the innermember is a pair of jaws 220 which is connected to the inner member at ahinge point 222. When the distal end of the inner member 214 isdisplaced from the inside of the outer sleeve 210 such that the hingepoint 222 is outside the outer sleeve, the jaws 220 assume their openposition as depicted in FIG. 4A. As the hinge point 222 is withdrawninto the outer sleeve 210, the outer sleeve forces the jaws 220 intotheir closed position, as illustrated in FIG. 4B. The opening andclosing of the jaws 220 can be accomplished by manipulation of thehandle portions 212 and 216.

The distal end of the grasping instrument 200 is configured to cut,puncture, or dilate tissue when the jaws 220 are in the closed position.In one embodiment shown in FIG. 4B, the jaws 220 havescrew-thread-shaped protrusions 224 on the surface. By rotating theinstrument as it passes through tissue, the protrusions 224 facilitatethe penetration of tissue, similar to a corkscrew. In another embodimentillustrated in FIG. 4C, the instrument has jaws 226 that form a sharptip 228 when closed. In yet another embodiment, the jaws form a bladewhich can cut through tissues when in the closed position. One of skillin the art would recognize that the above configurations can becombined, or that other configurations are possible which facilitate thepassage of the tip of the instrument through the wall of the stomach orother tissue.

It also should be realized to one skilled in the art that the closed endof the grasping device does not have to be the only instrumentresponsible for cutting through the tissue; the central lumen 230 of thedevice can be utilized to assist in tissue penetration. For example, aneedle (e.g. a Veres needle) 232 can be passed through the lumen and theneedle 232 can make the initial puncture through the tissue. Theconfiguration of the distal end of the grasper is meant to be a tissuedilator and facilitator of the entry into the stomach after the needlemakes the initial puncture. For safety, the needle can be retracted asthe tissue grasper dilates the tissue.

In the embodiment of the tissue grasper 200 illustrated in FIG. 4A, theinner member 214 and outer sleeve 210 have a central tunnel 230 thatextends the length of the tissue grasper. The tunnel 230 allows for thepassage of an expanding means such as a needle 232, or other instrumentor device such as the posterior or anterior anchor described above (seefor example, the description above regarding the connector-suturecombination in which the suture is left behind and the outer sheath ofthe connector is pulled away), through the length of the tissue grasperas shown in FIG. 4A. The central tunnel is also adapted such that aradially dilating sheath can be inserted through it. The diameter of thecentral lumen is preferably at least 4 mm, but can be at least 5, 6, 7,8, 9, 10, 11, or 12 mm. In an alternative embodiment, the distal jawscan be configured to close through an electromechanical means or purelymagnetic means such that the inner member is not necessary.

FIG. 5A illustrates one embodiment of an anchor implantation instrument250 to implant the anterior anchor. The implantation instrument has atubular outer sheath 252 which has a handle 254 attached. At the distalend, the outer sheath flairs out to an increased diameter 255 toaccommodate the anterior anchor in its substantially folded position asillustrated in FIG. 5C. Within the outer sheath is an anchor graspinginstrument 256 similar to the tissue grasping instrument of FIG. 4A,made up of a tubular middle sleeve 260 and a tubular inner member 264.The tubular middle sleeve 260 has an outer diameter such that it canslide within the outer sheath 252 in the longitudinal axis of the outersheath 252 but cannot move substantially transverse to the longitudinalaxis of the outer sheath 252.

The tubular middle sleeve 260 of the anchor grasping instrument has aportion of a handle 262 attached at the proximal end 261 of theinstrument. Disposed within the middle sleeve 260 is a tubular innermember 264 which has an outer diameter such that it can slide within themiddle sleeve 260 in the direction of the longitudinal axis of themiddle sleeve 260 but cannot move substantially in transverse to thelongitudinal axis of the middle sleeve 260. At the proximal end of theinner member, a second portion of a handle 266 is attached.

The distal tip 263 of the instrument is illustrated in more detail inFIGS. 5B and 5C, with the inclusion of the anterior anchor 40 of FIG. 2Aand connector 12 of FIG. 1A. FIG. 5C is a side section view taken alongthe line C-C of FIG. 5B. At the distal end 263 of the inner member 264is a pair of hooking members 270 which are connected to the inner memberat a hinge point 272. When the distal end of the inner member 264 isdisplaced from the inside of the middle sleeve 260 such that the hingepoint 272 is outside the middle sleeve, the hooking members 270 assumetheir open position as depicted in FIG. 5B. As the hinge point 272 iswithdrawn into the middle sleeve 260, the middle sleeve forces thehooking members 270 into a closed position, as illustrated in FIG. 5C.The opening and closing of the hooking members 270 can be accomplishedby manipulation of the handle portions 262 and 266.

The instrument is designed such that the anterior anchor is easilymanipulated. When the anterior anchor is in its substantially folded orcompressed configuration as in FIG. 5C, the entire anterior anchorassembly can be manipulated along the longitudinal axis of the connector12. FIG. 5C depicts the assembly as it would be introduced over theconnector 12 and into the patient. The operator pulls the connector 12toward the operator such that the posterior anchor is urged toward theanterior anchor. When in position, the operator deploys anterior anchor40. To deploy anterior anchor 40, outer sheath 252 is pulled back towardthe operator. Middle sleeve 260 is then withdrawn proximally toward theoperator as well. Hooking members 270 tend to fan out as the middlesleeve is pulled back and will release hooks 52. Once deployed, anterioranchor 40 is now fixed in a longitudinal position along the connector12.

If the surgeon wants to readjust the anterior anchor, connector 12 ismanipulated so that the hooks 52 of the anterior anchor are brought intocontact with hooking members 270; middle sleeve 260 is advanced distallyfrom the operator, permitting hooking members 270 to engage the hooks52; such contact is facilitated by pulling back (proximally) on theconnector 12. By manipulating the middle sleeve 260 over the hookingmembers 270, the hooks 274 on the ends of the hooking members 270 canengage the hooks 52 on the anterior anchor 40. The outer sheath 252 isthen slid over the anterior anchor 40 (or the anchor-middle sleevecomplex is withdrawn into the outer sheath 252), until it is compressedinto an undeployed configuration as shown in FIG. 5C. As describedabove, when the anterior anchor 40 is in a substantially compressedconfiguration, it can move along the length of the connector 12 ineither direction.

In an embodiment where an inflatable anterior anchor such as the oneillustrated in FIGS. 2G-2I is utilized (or in the case that the anterioranchor is otherwise sufficiently compliant to be pushed through alaparoscopic port), a standard laparoscopic grasping instrument (withteeth) can be used to manipulate the anterior anchor. When theinflatable anterior anchor is in the uninflated position, it issufficiently compliant such that it can easily be passed through alaparoscopic port prior to inflation and deployment or after it has beendeflated for readjustment; the middle sheath may not be necessarybecause the compliance of the balloon enables easy compression into theouter sheath. The inflation tube 63 passes through the laparoscopic portand out of the patient. This allows the inflation tube 63 of the anchorto be temporarily opened or closed outside the patient allowing fordeflation and reinflation until the anchor is in place. The inflationtube is then sealed and cut off, preferably substantially flush to thesurface of the anterior anchor.

Implantation of the Transgastric Fastening Assembly

FIG. 6A depicts the initial step of a preferred embodiment of a surgicalmethod to implant the transgastric fastening assembly. The first part ofthe procedure, the “percutaneous procedure” involves entering thestomach with an endoscope 300 and insufflating the stomach with a gas.When insufflated, the anterior wall of the stomach 302 is pushed towardthe anterior abdominal wall 304 to create a potential space (thestomach). After insufflation of the stomach, an incision is made in theskin and a standard laparoscopic port 306 is placed through the anteriorabdominal wall 304 to a position wherein the distal end is in thepotential space between the abdominal wall 304 and the anterior wall ofstomach 302. The laparoscopic port 306 can be a radially dilating typeport or similar port known in the art.

A particularly advantageous port is one which allows visualization (witha laparoscope) of the individual abdominal layers as it is being pushedthrough the abdominal wall (well known to those skilled in the art). Useof such a port allows the surgeon to “see” the different layers of theabdominal wall from within the trocar (using a standard laparoscopiccamera) as the trocar is advanced through the abdominal wall. Theendoscopic light inside the stomach will be “seen” by the surgeon as theport approaches the inner layers of the abdominal wall because theendoscopic light source transilluminates through the layers of thestomach wall and inner layers of the abdominal wall. Such visualizationis advantageous if the patient has a very thick abdominal wall (e.g. ina morbidly obese patient) because the surgeon needs to ensure thatanother organ (e.g. the colon) is not positioned between the stomach andthe posterior wall of the abdomen. Once the transillumination of thestomach is visible through the transparent port, the port 306 can beslipped in the abdomen between the abdominal wall and the anterior wallof the stomach. This portion of the procedure can be done withoutpneumoperitoneum and without general anesthesia. At this point, a cameracan be placed inside the laparoscopic port to visualize the anteriorwall of the stomach. Visualization of the surface of the stomach canalso be achieved with this method and does not require generalpneumoperitoneum. The camera can be slid along the stomach to reachvirtually any portion of the anterior stomach or duodenal wall.Additional ports can also be placed in the space between the abdominalwall and the anterior wall of the stomach. At this point in theprocedure, a therapeutic energy device can be applied to the stomach.For example, a laser, a radiofrequency device, a microwave device, or anultrasound device can be applied to the stomach. Furthermore, electricalor nervous mapping can be performed with the surgical device in theposition between the anterior wall of the stomach and the abdominalwall. In the embodiment where an extragastric balloon is being deployed(see below), such deployment proceeds at this step. Furthermore, in theembodiment where balloons are placed inside the stomach or neuro- ormuscular stimulators or other devices are placed, they are implanted atthis step and do note require general anesthesia and do not requiregeneral anesthesia.

In an alternative embodiment, “the laparoscopic procedure,” apneumoperitoneum is created through a separate incision in the skin. Averes needle, or other standard method to create a pneumoperitoneum (asis well-known to surgical practitioners) is used to insufflate theabdominal cavity.

In the percutaneous procedure, the tissue grasping instrument 200 ofFIG. 4A is inserted through the port 306 with the jaws 220 in the closedposition (with or without a needle projecting in front of theinstrument) and is passed through the anterior wall of the stomach 302.When the jaws of the instrument are closed, the jaws define a sharp,dilating, and/or cutting configuration which can more easily advancethrough the stomach wall.

FIG. 6B depicts the next step in the percutaneous procedure. The jaws ofinstrument 200 are used to grasp the posterior wall of the stomach 314.The posterior wall of the stomach 314 is lifted away from theretroperitoneum 316, allowing for access to the potential space of thelesser peritoneal sac 320. A needle 232, such as a Veres needle(well-known in the art, a Veres needle allows for easy and safe accessinto and between two serosal layers), is inserted through the centralchannel 230 of the instrument and passed through the posterior wall ofthe stomach 314 into the potential space of the lesser peritoneal sac320. The potential space of the lesser peritoneal sac 320 is expanded byinjection of a gas, such as carbon dioxide, through the needle 232. Inother embodiments, the potential space is expanded using a liquid, gel,or foam. Alternatively, the space can be expanded using a balloon orother space expanding or space filling device; alternatively, a surgicalinstrument (e.g. electrocautery and/or blunt ended grasper, etc.) can beused in place of a needle to access the lesser peritoneum or to expandthe potential space of the retroperitoneum 320. Preferably, the expandedspace of the lesser peritoneal sac can extend from the angle of His atthe gastroesophageal junction to the pylorus.

In an alternative embodiment, the space is not expanded before theposterior anchor is placed. For example, in an embodiment where aninflatable posterior anchor is used, the potential space can be expandedby the anchor itself as it is inflated to its deployed configuration.

FIG. 6C depicts the next step in the “percutaneous procedure”embodiment. With a direct path from outside the patient to the lesserperitoneal sac 322, the needle 232 is withdrawn from the instrument 200.An optional dilation step can be performed at this stage in theprocedure using a device such as a radially dilating sheath (e.g.InnerDyne STEP™ system; Sunnyvale, Calif.) inserted through the centralchannel 230 of the instrument. The dilating device expands the openingin the posterior wall of the stomach in such a way that the openingcontracts down to a lesser profile after dilation. A posterior anchor324 and connector 326, such as those depicted in FIG. 1B, 1E orpreferably 1F, in its reduced profile configuration, is passed throughthe central channel 230 of the instrument, through the posterior wall ofthe stomach 314, and deployed in the lesser peritoneal sac 322 as shownin FIG. 6C. Where the optional dilation step is performed, the posterioranchor 324 is passed through the dilating sheath. The connector 326 ispreferably of sufficient length to pass from inside the lesserperitoneal sac 322 through the central channel 230 of the instrument andout of the patient's body. FIG. 6D depicts the deployed posterior anchor324 and connector 326 after the grasping instrument is withdrawn fromthe patient and tension is applied to connector 326 to pull theposterior anchor 324 against the posterior wall of the stomach 314.

In the “laparoscopic embodiment,” after insufflation of the abdominalcavity with a Veres needle, a retrogastric tunnel is created as is wellknown in the surgical art and is shown in FIG. 15 a. The posterioranchors 510 are shown as a component of the retrogastric instrument inFIGS. 12 and 15 a. The posterior anchors 308 are also shown in FIG. 6E.The suture-connector system 309, 311 depicted in FIG. 1H-J is alsodepicted in FIG. 6E and is used in one of the laparoscopic embodiments.Connector 309 engages anchor 308 and locks suture 311 into posterioranchor 308. Connector 309 is then slid over suture 311 prior to theanterior anchor (FIG. 13; 550) being slid over (tracking) the connector311.

FIG. 12 depicts one step in one laparoscopic embodiment; a laparoscopicinstrument 500 is provided which has a reversibly attached anchor 510.Grips 520 reversibly grip anchor 510. Any of a variety of grippingmechanisms can be employed to retain the anchor 510 on laparosopic tool500. Connector 332 is substantially similar to any of the connectorsdescribed above except that the posterior anchor 510 is not attached toconnector 332 when it is inserted through the anterior abdominal wall.The surgeon places laparoscopic tool 500 behind the stomach 428 of thepatient and connector 332 is advanced through lumen 545 formed inpatient's skin 535 and anterior abdominal wall 530. Connector 332 isthen further advanced percutaneously through first and second walls 540and 547 of stomach 428.

When the connector 332 reaches the posterior anchor 510, grippingelements 520 are released by the surgeon through a mechanism which isintegrated into the laparoscopic tool 500. Connector 332 is fixed toposterior anchor 510 through a locking mechanism. Mechanisms of lockingconnector 332 to posterior anchor 510 are well-known to those skilled inthe art of mechanical fixturing. Some or all of the fixturing mechanismsmay reside on the connector or on the anchor. In another embodiment, thegripping force of the grippers 520 can be overcome by force applied bythe surgeon on connector 332. Mechanisms of locking other thanmechanical also exist and include magnetic, electromagnetic, andadhesive means.

An anterior anchor 550 (FIG. 13) is then placed over the connector 332by the methodology and devices described in the next paragraph; themechanism of deploying the anterior anchor is the same in both the“laparoscopic” and “percutaneous” procedures. The walls of the stomachare urged together (FIG. 14) to create a resistance to the flow of foodwithin the stomach. 570 depicts one side of the stomach after the wallsof the stomach are urged together. 570 is the side of the stomach wherefood enters. Its volume and capacity are now reduced as compared to itsoriginal volume and capacity. Although not shown, connector 332 issubsequently truncated at the level of the anterior anchor 550 after theanterior anchor is deployed and by any of the mechanisms described anddepicted above.

FIG. 7A illustrates the step of implanting the anterior anchor. Theconnector 326 is inserted through the hole or other passageway of ananterior anchor 40 of FIG. 5C, and the anchor implantation instrument250 of FIGS. 5A, 5B and 5C is used to slide the anchor 40 through thelaparoscopic port 306 into the abdomen of the patient. The anterior 302and posterior 314 walls of the stomach are urged together, either byusing the anchor implantation instrument 250 to urge the anterior wall302 toward the posterior wall 314, or by pulling on the connector 326and posterior anchor 324 to urge the posterior wall 302 of the stomachtoward the anterior wall 314, or by a combination of the two methods.Once the anterior anchor 40 is in the desired position, the anterioranchor 40 is placed in its deployed configuration by manipulating theanchor implantation instrument 250 as described above.

In a preferred embodiment, the inflatable anterior anchor of FIGS. 2G-2Iis used, and the use of the implantation instrument of FIG. 5C isoptional. After the anterior anchor is in the desired position, theanterior anchor is inflated with a filling substance through theinflation tube until it is in its deployed configuration. The grippingelements 67 and teeth 68 are thus engaged against the connector 326. Theanchor implantation device 250 can then be withdrawn from the patient'sabdomen.

With the transgastric fastening assembly complete, the surgeon canexamine the resulting configuration of the stomach using an endoscope.If the anterior anchor is not in the desired location, its placementalong the connector can be adjusted as described above. Alternatively,in another embodiment, the anterior anchor can be urged closer to theposterior anchor simply by pushing it along the connector without usingthe implantation device to capture the anchor and deform it into itsreduced profile configuration.

In another embodiment, the anterior anchor can be deflated, allowing theanterior anchor to be repositioned, and then reinflated to engage theconnector. FIG. 7B illustrates the transgastric fastening assembly withthe anterior anchor 40 in its deployed configuration on the connector326 and the anchor implantation instrument removed from the patient'sabdomen. The anterior 302 and posterior walls 314 of the stomach havebeen urged closer together by the transgastric fastening assembly.Whether the walls of the stomach are urged into contact or not isdetermined by the surgeon. Contact between the mucosal surfaces can beloose such that food can go through yet a significant resistance isprovide; alternatively, mucosal surfaces are urged together to touch butfood cannot pass through the apposition.

FIG. 7C depicts a transgastric fastening assembly in its finalconfiguration after deployment. Once the surgeon is satisfied that thetransgastric fastening assembly is properly placed, a cutting implement,well-known to those of skill in the art, is inserted through thelaparoscopic port and the connector 326 is cut, preferably flush to theanterior anchor 40. In some embodiments, the cutting instrument isplaced over the connector (tracks) with the connector as a guide. In anembodiment, where inflatable anchors are used, the hollow connector andinflation tube are sealed prior to, or as a result of, cutting,preventing anchor deflation. Alternatively, if a filling substance whichhardens with time is used, it may not be necessary to seal the connectoror inflation tube prior to cutting if the filling substance issufficiently hard or viscous such that it will not leak from theconnector or inflation tube.

When more than one transgastric fastening assembly is to be implanted,it is sometimes preferred to insert all of the posterior anchors andconnectors before attaching any or all anterior anchors; in someembodiments, an instrument to measure tension is used to measure thecompression of the stomach mucosa prior to the operation. This is incontrast to attempting to place one complete transgastric fasteningassembly and then subsequent assemblies. While possible, if one were toplace entire fastening assemblies in series, each successive assemblywould be more difficult to place because the volume of the stomach wouldbe progressively reduced resulting in more difficult visualization eachtime.

FIG. 8A depicts an embodiment in which two posterior anchors 330 andconnectors 332 are deployed in the expanded lesser peritoneal sac. Inthis embodiment, there is one laparoscopic port 334 for each connector332. Alternatively, there may be more anchors placed than incisions andlaparoscopic ports. Depending on how far apart the anchors are placed, agiven laparoscopic port can be used to implant a plurality oftransgastric implants. This can be accomplished because there issignificant mobility of the stomach and/or abdominal wall which allowsfor different points along the anterior wall of the stomach to beaccessed without having to create another hole through the abdominalwall.

When it is desired to place more than one set of transgastric assembliesand in particular when the assemblies are placed concurrently ratherthan sequentially, the surgeon is afforded the opportunity to test (e.gmeasuring stomach volume, resistance to flow, assessing mucosalintegrity, etc.) varying tensions on one or more of the fasteningassemblies, all under endoscopic inspection. After the desired number ofposterior anchors and connectors are deployed in the patient, theconfiguration of the stomach can be tested by applying tension to theconnectors. FIG. 8B depicts temporary clamps 336 which sit on top of theports 334. In some embodiments, the clamps are tensiometers whichquantify the tension between the anchors. Connectors 332 can be pulledfrom outside the abdomen to urge the posterior wall of the stomach 340toward the anterior abdominal wall 342. One or more clamps 336 can thenbe closed to hold the stomach in a test position. To determine if theposterior anchors 330 are in the desired location, an endoscope 344 canbe used to view the configuration and the tension that the stomach willendure after the anterior anchors are placed.

In an alternative embodiment, the stomach is fastened to the abdominalwall rather than there being a free space between the anterior gastricwall and the peritoneum of the abdominal wall (not shown). The initialsteps are as discussed above. After the posterior anchors are placed,their position can be tested as depicted in FIG.8B to simulate theconfiguration after the anterior anchor is placed. Next, the outerlaparoscopic port is pulled back so that the anchor deploying instrumentdirectly contacts and sits within the tissues of the muscular abdominalwall. Once the outer laparoscopic port is pulled back, the anterioranchor can be deployed within the abdominal wall musculature and theconnector can be cut flush with the anterior anchor. In an embodimentwhere the inflatable anterior anchor is used, after the anterior anchoris deployed within the abdominal wall musculature, the inflation tube iscut, preferably flush with the anterior anchor.

Reversal of the Gastric Volume Reduction Procedure

The connector of a preferred embodiment of the deployed transgastricfastening assembly, as illustrated in FIG. 7C, can be cut at a pointbetween the anterior and posterior anchors, which results in reversal ofthe gastric volume reduction. The connector is preferably made to resistcorrosion from stomach acid, but is able to be cut by a cuttingimplement advanced through an endoscope into the stomach. In the Smithpaper (full reference above), a nylon suture was used to traverse thestomach in the anterior-posterior direction and attach the pledgets tothe walls of the stomach. The nylon material was suitable for use forover 3 years without any indication of corrosion (Smith, L. et. al.Results and Complications of Gastric Partitioning. The American Journalof Surgery. Vol. 146; December 1983). Other materials suitable toprevent corrosion and yet allow cutting include plastics such aspolyurethane, silicone elastomer, polypropylene, PTFE, PVDF, orpolyester, metals and metal alloys such as stainless steel,nickel-titanium, titanium, cobalt-chromium, etc. Once the connector iscut, the walls of the stomach are free to move away from one another,thereby reversing the procedure. Reversal of the procedure can occur atany time (days to years) after the procedure. In a preferred embodiment,the anchors remain in the gastric wall permanently even after theconnector is cut or otherwise divided. Alternatively, the anchors can inpart or in whole be manufactured from a bioabsorbable material such thatthe anchors will eventually be absorbed by the body. In the case ofbioabsorbable anchors, it is preferable to have a connector which is atleast in part bioabsorbable. In another embodiment, substantially all ofthe elements of the transgastric fastening assembly are made ofbioabsorbable materials, with the intent that over the desired period oftime, the entire assembly will be absorbed by the body, reversing theprocedure without any additional actions required by a doctor. Inanother embodiment, the anchors are made of a non-reactive material suchas silicone. In this embodiment, reversal of the procedure requires a“laparoscopic procedure;” that is, pneumoperitoneum. The connector iscut with the endoscope and then the anchors are removed with standardlaparoscopic instrumentation; being composed of silicone, the anchors inthis case will be easily removed.

Even if there is some degree of fusion between the mucosa around theconnector at the region of the assembly, once the connector is cut orabsorbed, the walls will tend to move apart over time. Alternatively, aballoon or other dissection device is introduced through an endoscopeand used to separate the walls of the stomach at the point of fusion.

Treatment of Disease Conditions

The devices, methods and instruments disclosed above can be used totreat obesity and other diseases involving the gastrointestinal tract,such as gastroesophageal reflux disease (GERD). FIG. 9 depicts threetransgastric fastening assemblies 400 deployed longitudinally in thestomach; such a configuration of anchors results in a tubularconfiguration of the remaining portion of the stomach The dashed linesrepresent boundaries of the divisions of the stomach: the cardia of thestomach 402, the fundus of the stomach 404, the body of the stomach 406,the antrum of the stomach 408, and the pyloric sphincter 410. In apreferred embodiment, the fastening assemblies are not implanted in theantrum 408 in order to maintain the normal digestion process of thestomach. Normal digestion occurs in the antrum which precedes passage offood into the duodenum. In stopping short of the antrum 408, theimplants replicate the degree of volume reduction of the Magenstrasseand Mill (M&M) procedure (discussed above).

Food ingested by the patient follows a physiologic pathway for digestiondepicted by the arrow in FIG. 9. It travels through the esophagus 412and enters the cardia of the stomach 402. The food is digested in thestomach and pushed toward the duodenum 414 as chyme for furtherdigestion. The preserved antrum 408 allows for relatively physiologicdigestion and emptying into the duodenum 414 akin to the M&M procedure.With transgastric fastening assemblies 400 in place, food which leavesthe esophagus 412 and enters the stomach, results in increased walltension on the lesser curvature of the stomach 416 as the greatercurvature of the stomach 418 will be restricted from the food pathway.The path of least resistance will be the path toward the pylorus 410 andduodenum 414. The increased wall tension of the stomach will result in afeeling of satiety by the patient, leading to decreased food intake andweight loss. Although three assemblies are shown in FIG. 9, there may beas few as one or as many as ten depending on the degree of volumereduction desired. Such flexibility in number of devices as well as theability of the surgeon to tune the tension between the anterior andposterior anchors is advantageous. Such flexibility may enable, forexample, reversal of a few anchors rather than all the anchors, suchthat the volume reduction procedure is partially reversed.

In another embodiment, a transgastric fastening assembly is placed inthe antrum 408 or the region just proximal to the pyloric sphincter 410if deemed necessary by the gastroenterologist and/or surgeon. Such aconfiguration would not reduce the volume of the stomach but would causea feeling of fullness similar to a gastric outlet obstruction, leadingto decreased food intake and weight loss. The anchors in this region canalso conduct a current to electrically stimulate the stomach to simulatesatiety.

In another embodiment, a transgastric fastening assembly may be requiredat the region of the cardia 402 to treat morbid obesity in a similarmanner to that utilized with the LAP-BAND™ (Inamed Corp., Santa Barbara,Calif.). In this embodiment, the transgastric fastening assembly is notutilized to reduce the volume of the stomach, but to create arestriction to the inflow of food. In this embodiment, the fasteningsystem can traverse the cardia but will not completely oppose (or atleast will not prevent the flow of food through the fastening system)the mucosal surfaces of the anterior and posterior walls of the stomach.

In another embodiment, the surgeon or gastroenterologist may choose totreat a disease such as gastroesophageal reflux disease (GERD) with atransgastric fastening assembly in the cardia region. Such aconfiguration would maintain the position of the GE junction in theabdomen and potentially create a barrier to reflux contents.

In another embodiment, the disclosed method in combination with thetransgastric fastening assemblies can be adapted to attach agastrointestinal organ to the abdominal wall which in addition toreducing volume can also create a kink in the organ. The kink wouldcause a resistance barrier (in addition to volume reduction) togastrointestinal contents, and can be useful to treat reflux disease ormorbid obesity.

Such a kink would also fix the gastrointestinal region to the abdominalwall can also maintain the reduction of a hiatal hernia in the abdominalcompartment (e.g. in reflux disease). A major component of refluxdisease is a hiatal hernia in which the gastroesophageal junction freelyslides from the abdomen to the mediastinum. A percutaneously placedsuture or anchor in the region of the gastric cardia and/or fundus cantether the junction to the abdominal wall and confine the junction tothe abdomen.

In other embodiments, the devices and methods of this invention canassist in the implantation of devices such as stents, meshes, stitches,or tubes in the gastrointestinal tract. The major technical difficultyencountered in placing stents, tubes, balloons, stimulators, and meshesinside the lumen of the gastrointestinal tract is that they tend tomigrate because the walls of such devices do not adhere to slipperymucosa. A transgastric or transintestinal anchor, implanted with thecurrent instrumentation could solve this problem. Such a method would beparticularly useful in the attachment of the stent part of thestent-sleeve system outlined in patent application WO 04049982, or themesh of patent application WO03086247A1. In another example, devicessuch as those disclosed in patent U.S. Pat. No. 6,773,441 attempt toplace an endoscopic stitch to tether the cardia of the stomach to thefundus to treat reflux disease. Such stitches are tenuous in the longterm because they do not necessarily penetrate the serosa. Even if thestitches penetrate the serosa, they tend to erode through the wall withtime because of their thin profile and an inability of the endoscopicoperator to control tension on the suture when it is placed. With themethods and devices of this invention, such an endoscopic suture can bebuttressed with a percutaneously placed anchor.

Other Embodiments of the Disclosed Devices, Instruments and Methods

Although the described methods are focused on the implantation oftransgastric fastening assemblies to reduce the volume of the stomach orto increase the resistance to the flow of food in the stomach, themethods and devices can easily be expanded to the placement of othertypes of devices such as neurostimulators, gastric muscle stimulators,gastric balloons, and bulking devices inside the wall of agastrointestinal organ using the percutaneous methods and devicesdescribed herein.

The methods can further be used to apply an energy source to an internalorgan. For example, the methods and devices of the current invention canbe used to apply radiofrequency probes, microwave probes, ultrasoundprobes, and radioactive probes in similar ways as disclosed in PCT WO00/69376. The methods can further be used for diagnostic purposes priorto performing a surgical therapy. In one example, the methods anddevices are used to identify specific nerves or nerve plexuses prior toa delivering a specific therapy. In another example, specific hormoneproducing, such as ghrelin are identified prior to delivering a specifictherapy.

In one embodiment of the current invention, a neurostimulator orneurostimulator lead is placed in the serosal layer of the stomach orsmall intestine to stimulate the muscular or nervous portion of thestomach or small intestine (e.g. the duodenum). In some embodiments, thestimulator contacts and acts on the parasympathetic, the enteric, or thesympathetic nervous system; in other embodiments, the stimulator acts onthe muscular portion of the stomach. The stimulator can be placedanywhere along the stomach including the anterior and/or posterior wallsof the stomach. In some embodiments, the stimulator contacts the mucosaand in other embodiments, the stimulator does not contact the mucosa. Insome embodiments, a sensor is placed as a component of the stimulator oras a separate device. In some embodiments, the stimulator furthercommunicates with a second or third stimulator. In one embodiment, asensor is implanted using the methods and devices described herein; thesensor can communicate with the stimulator. In one example, the sensoris placed in the stomach wall and senses stretch in the stomach. Thissensor communicates with the stimulator device to create a feedback loopin which stretch is sensed (the sensor) and then a signal is sent to thestimulator portion of the system (the effecter) wherein a nerve (forexample, the vagus nerve or sympathetic plexus) is stimulated to promptthe patient to slow their food intake. The effecter of the feedback loopdoes not have to be a nervous structure and in some embodiments is amuscular portion of the stomach or duodenum such as the pyloric channel,the antrum, the cardia, or the fundus. In some embodiments, the effecteris a patient stimulus such as a small electrical current under the skinto inform the patient, that the stomach is full. The current or effecterportion of the feedback loop can increase in intensity if the patientignores the signal and continues to push food into the stomach cavity.

In some embodiments, the methods and devices described herein to placedevices inside or outside the stomach; inside or outside the lesser sacof the peritoneum; inside or beside a structure within theretroperitoneum; inside, beside, or outside the duodenum, pylorus, orgastroesophageal junction. Implanted devices include but are not limitedto the anchor devices and transgastric fastening assemblies describedabove, stents, meshes, stent-grafts, stitches, and bulk forming agentscan be placed as well.

In one embodiment, a transgastric fastening assembly serves to reducethe volume of the stomach as well as provide for electrical stimulation.In this embodiment, an electrical signal runs through electrodes in thetransgastric fastener assembly to alter the contraction patterns of thestomach or to electrically create a feeling of satiety in addition toreducing the volume of the stomach and creating a restriction to flow inthe stomach. Thus, fastener assemblies of the present invention canbecome electrodes which are useful, for example, for gastric electricalstimulation. Methods and devices of this invention can also be used toplace sutures in the stomach or pylorus to treat reflux disease orobesity. Such suturing would be facilitated by the placement of multipleports through the walls of the stomach. Any of these methods and devicescould be used in combination with or in place of the transgastricfastening assemblies to induce weight loss in a patient.

In another embodiment, the novel methods, implantation devices, andanchors of this invention are used to implant devices in one wall of agastrointestinal organ without volume reduction. One example of such anembodiment is illustrated in FIGS. 10A and 10B in which a balloon-likedevice is deployed in the stomach to displace volume rather than toreduce volume from the outside. The internal balloon 430 is similar tothe posterior anchors in some of the embodiments described above. In oneembodiment, after initial insufflation of the stomach and placement of alaparoscopic port 306 (percutaneously and without pneumoperitoneum)between the abdominal wall 304 and the anterior wall of the stomach 302,an instrument is used to penetrate only the anterior wall of the stomach302 and place an inflatable intragastric balloon 430. Inflation isachieved through the connector lumen 432 and the balloon is placedwithin the interior of the stomach 428, as illustrated in FIG. 10A. Wheninflated, the balloon 430 is preferably spherical in shape such that itoccupies a substantial portion of the stomach volume when inflated. Inthe embodiment shown, the connector also acts as the inflation tube forinflating the intragastric balloon. In another embodiment, in additionto the connector, there is a separate inflation tube similar toembodiments presented above. As discussed above, a valve can be locatedbetween the anchor and the connector, or alternatively outside thepatient. Preferably after the intragastric balloon is inflated and ananterior anchor 434 is deployed on the connector 432, as describedpreviously. The connector is also cut, preferably flush with theanterior anchor, and the laparoscopic port is removed, as shown in FIG.10B. The anchor portion of the intragastric balloon is then fixed in thewall of the stomach. In the preferred embodiment where an inflatableanterior anchor 434 is used, the inflation tube is also cut, preferablyflush with the anterior anchor. Other devices which may only beimplanted in one gastric wall include neurostimulators, muscularstimulators, sensors, and pharmaceutical delivery devices.

In another embodiment, an extragastric balloon is used to reduce thevolume of the stomach and/or create a barrier to the flow of food and arestrictor to the flow of food. FIG. 11 a depicts the balloon 430 in theundeployed configuration. The balloon is placed through a trocar port306 which is placed in between the peritoneum and anterior wall of thestomach as described in detail above. FIG. 11B shows an embodiment of anextragastric balloon 430 in its deployed state. The balloon 430 isattached to the abdominal wall by any of the percutaneousanchor-connector assemblies and methods described above. Stem 432 is theresidual from the connector used to place the balloon with an optionalaccess port for further inflation and/or deflation after the balloon isplaced. In some embodiments (FIG. 11 c), the posterior portion of theballoon 436 is fixed to the outer portion or inner portion of thestomach using any of the fastening systems described above. Theposterior portion of the balloon can also be fixed to the anteriorgastric wall with an anchor delivered through the stomach with anendoscope. The extragastric balloon can be placed anywhere along thestomach, even at a position 1-5 cm below the gastroesophageal junctionat the same place where laparoscopically placed gastric bands arecurrently placed. The balloon can further be shaped to circumscribe astructure such as the gastroesophageal junction.

FIG. 18 embodies another use for the current invention. The sleevedevice 620 is disclosed in US patent application publicationUS2004/02206882. A major difficulty with this sleeve device is that itis not easily fixtured for stability inside the stomach. Fasteningsystem 610 is used to assist in fixation of the device 620 to thestomach wall; fastening system 610 is any of the devices discussed aboveand is implanted by any of the methods discussed above.

In another embodiment, a surgical anastomosis is surrounded with theorgan spanning anchors and anchor assemblies of the current invention.In this embodiment, the anchors can buttress the anastomosis to protectthe integrity of the anastomosis. The buttresses support both thehand-sewn and the stapler anastomotic techniques. To prevent or supportleaks, the anchors are placed around or through the anastomosis.

The anchors can also be used to control the flow of material through theanastomosis. Flow control is attainable when two anchors are appliedacross an anastomosis and are linked by means of a connector through theanastomosis. The distance between the anchors determines the amount offlow through the anastomosis and therefore, the flow rate can beadjusted quite readily with the device of the current invention. Theflow rate is adjustable at anytime during or after the operation.Luminal devices to control the flow rate through an anastomosis can befound in patent application number 20050022827. The devices of thecurrent invention can be used to accomplish the goal of controlling flowthrough an anastomosis by placing anchors that traverse the anastomosis.In other embodiments, the anchors of the current invention can be usedto secure the luminal devices in patent application number 20050022827.

In another embodiment, the anchor assemblies are applied to the lung totreat chronic obstructive pulmonary disease (COPD) via functional lungreduction. Rather than removing a portion of the lung (the surgicalprocedure), the anchors of the current invention are placed through thediseased portion of the lung to close off or at least create a largeresistance in one portion of the lung and broncheoalveolar tree so thatinspired air does not reach a malfunctioning portion of the lung.

Similarly, the anchor assemblies and anchors are applied to other solidorgans such as the spleen, kidney, liver, and pancreas to urge the edgesof a defect together to promote healing.

In other embodiments of the current invention, the fastening systems andtools to implant the fastening systems are used to secure closure orrepair of blood vessels. The blood vessels can be named vessels such asthe aorta, vena cava, pulmonary veins, pulmonary arteries, renal vein,renal artery, inferior mesenteric vein and/or artery, splenic veinand/or artery, portal vein and/or hepatic artery. Alternatively, thevessels are unnamed such as in the case of the mesentery of the colon orsmall bowel. Vessel closure with the current system is possibly moreefficient than current laparoscopic means of vessel closure whichinvolve staple or clip occlusion of the vessels; however, staples andclips are often inadequate because they do not penetrate the vessel tocreate occlusion and therefore are often inadequate, or at least do notreplicate what a surgeon would do in an open procedure.

It is also possible that a part of, or any or all of the devices andmethods described above are performed with an alternative imaging means;for example, fluoroscope, MRI, CAT scan.

Although the present invention has been described in the context ofcertain preferred or illustrative embodiments, it should be understoodthat the scope of the exclusive right granted by this patent is notlimited to those embodiments, but instead is the full lawful scope ofthe appended claims.

1. A method for reducing the stomach volume in a patient comprising thesteps of: a. Placing an inflateable balloon through a trocar and intothe abdominal cavity of the patient in an undeployed configuration; b.Deploying the inflateable balloon inside the abdominal cavity betweenthe abdominal wall and the anterior wall of the stomach; c. Attachingthe balloon to the abdominal wall using at least one attachment site onthe balloon.
 2. The method of claim 1 further comprising the step ofInflating the balloon through an inflation channel.
 3. The method ofclaim 1 wherein said balloon further comprises an attached mesh andfurther comprises attaching said mesh to the abdominal wall of apatient.
 4. The method of claim 1 wherein said balloon conforms to aportion of the stomach when the balloon is inflated and furthercomprises positioning the balloon over a region of the stomach.
 5. Asystem to create satiety in a patient comprising: a. An inflateableballoon configured to reduce the volume of the stomach when inflated andwhen the balloon is attached to the abdominal wall and not the stomach;b. A fastener adapted to secure the balloon to the abdominal wall. 6.The system of claim 5 further comprising a surgical access port adaptedto house the inflateable balloon when the inflateable balloon is in anundeployed state.
 7. The system of claim 5 further comprising a meshwhich contacts a portion of the the balloon.
 8. The system of claim 5wherein said balloon conforms to the shape of at least a portion of thestomach when inflated.
 9. The system of claim 5 wherein said fastener isadapted to attach the balloon to the abdominal wall from within theabdominal cavity.
 10. A method of inducing satiety in a patientcomprising the steps of: a. Placing a single inflateable balloon througha trocar and into the abdominal cavity in an undeployed configuration;b. Deploying the inflateable balloon inside the abdominal cavity betweenthe abdominal wall and the anterior wall of the stomach; c. Attachingsaid balloon to the abdominal wall using an attachment fixture; d.Positioning said balloon so that a portion of the balloon conforms tothe curvature of the stomach.
 11. The method of claim 10 wherein saidfixture is a mesh.
 12. The method of claim 10 wherein said mesh isconstructed so as to induce tissue ingrowth.
 13. The method of claim 10wherein said attachment fixture is adapted to fix the balloon to theabdominal wall from within the abdominal cavity and further comprisesattaching said balloon to the portion of the abdominal wall within theabdominal cavity.